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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Professional Development across the Term of an HREC Committee Member0

 

AHRECS has considerable experience working with universities, hospitals, research institutions, government and non-government organisations to care for and build the capacity of its HREC Committee members across the entire term of their appointment. We start with the needs of our clients and offer support from recruitment all the way through to running an exit interview.

Many HRECs have quite simple manual-based inductions; we help HRECs to create something more welcoming and interactive that takes members from first contact to the point where they can contribute effectively to a committee. There is a significant difference between delivering a single ‘training session’ and creating a suite of professional development activities over two to three years, that covers committee members’ terms, and that might include dedicated annual PD and Strategy sessions and incorporate ongoing PD into each HREC meeting.

We can:

  • help recruit expert external members to meet the needs of specific HRECs
  • create interactive and multi-media induction and orientation materials
  • introduce members to the broader literature on research ethics
  • create material and run professional development sessions tailored to the specialist roles of particular HRECs
  • evaluate the performance of the HREC and provide feedback to the HREC and its host institution
  • offer exit interviews to HREC members stepping down from their role, and then….
  • help recruit replacement members to HRECs

We have provided elements of such services in Australia, Canada, Mauritius, New Zealand, Taiwan, United Kingdom, United States and Vietnam for new and established, small and large institutions and consortia of research organisations.

Contributor
Prof. Mark Israel, AHRECS senior consultant
AHRECS profile page
mark.israel@ahrecs.com

This post may be cited as:
Israel M. (2017, 22 June) Professional Development across the Term of an HREC Committee Member. Research Ethics Monthly. Retrieved from: https://ahrecs.com/services/professional-development-across-term-hrec-committee-member

Research Ethics in the Philippines: a personal journey0

 

My recall of the earliest encounter I had with research ethics is when, as a newly appointed faculty member of the department of obstetrics and gynecology of the College of Medicine (CM) of the University of the Philippines (UP) and concurrent attending at the Philippine General Hospital (PGH), I rushed to the office of the ethics research committee (known as the Research Implementation and Development Office or RIDO) of CM before the end of office hours one Friday. In my hand was a letter, addressed to the then chairman requesting approval of a study I was about to conduct. Attached to the letter was a one page synopsis of the research protocol. I was fortunate enough to catch him on his way out of the office, and doubly lucky he agreed to quickly browse through the papers I pushed in front of him. He then instructed the office secretary to stamp the letter “APPROVED”, and proceeded to affix his signature. It was in the early 1990’s!

His stamp of approval went a long way towards legitimizing the outcome of my research. I was able to collect and isolate N. gonorrhoea from commercial sex workers in Manila and Cebu, freeze dried all 92, and transport them hand-carried to the laboratory of at the University of Washington. It turned out, almost all the isolates were resistant to the standard first line drug (ciprofloxacin) at that time. Interestingly, a few months before, my collaborator from the US walked into our office looking for someone to work with. Apparently, a US male citizen had been diagnosed to have ciprofloxacin resistant gonorrhea infection. He admitted to having paid sex in Manila and Cebu prior to flying back home. Fate would have it that I was in the office when my collaborator walked in. And since my sub-specialty in obstetrics and gynecology is in infectious disease, the rest was history. I am including this in my narrative because ordinarily, researches with no international collaboration and/or funding would not warrant a mandatory ethics research committee approval. If the process I went through at that time could be construed as a legitimate one today!

Soon after I finished the gonorrhea study, I found myself being appointed by our department chairman to be the representative to the same ethics research committee (RIDO)! By then, in the early years of 1990, all basic science departments of CM and all clinical departments of PGH appointed representatives to RIDO. Meetings were conducted almost monthly to discuss and evaluate research protocols of faculty members who cared to submit their protocols. In those early times, these usually were those with external funding such as clinical trials, or those with international collaborations. I seem to remember the chair of RIDO would present a brief summary of the protocol at hand for the consideration of the members present. If there were no major objections, the research protocol gets approved, and the study will proceed. There didn’t exist written guidelines and standard operating procedures for RIDO. That was in the later years of 1990 and early years of 2000.

When the chair of RIDO retired from the College of Medicine, she recommended me as her replacement. By then, the beginnings of guidelines and standard operating procedures have been put in place. The developments in the interest and commitment to research ethics were being fueled not only within the walls of the academe (CM, PGH and UP), but also in the scientific community. The creation of the National Institutes of Health in UP Manila, whose mandate is to spearhead research at par with the international community, played a big role in upgrading the standards of research, and along with it, compliance to international standards of conducting ethical review of research involving human participants. A Fogarty International grant to UP Manila, whose prime mover was Professor Leonardo D. de Castro, PhD of the College of Social Science and Philosophy of UP Diliman, made it possible to create training programs which empowered the academe in bioethics. In fact in the early years of 2000, a Diploma course in Bioethics was approved and offered through the collaborative efforts of UP Manila and Diliman campuses. Unwittingly, for what I consider to be totally less noble reasons, I took the Diploma course. My main reason was not to help promote research ethics specifically. It was really more for my professional development. At that time, I was already a tenured faculty member. But the trend in the academe was for younger members, even though not yet tenured, to proceed to obtain masteral and even doctoral degrees. My thought at that time was I didn’t want to be upended by younger colleagues. So I enrolled and finished the Diploma course in Bioethics. A year thereafter, the full Masteral course was approved and offered. I proceeded to re-enroll for the same main reason and motivation. It took me several years and 3 extensions of the maximum residency rules of the University before I was able to finish and defend my thesis, and get my Masteral degree in Bioethics!

The prime movers of the bioethics program UP Manila were from the College of Medicine headed jointly by Dra Marita Reyes and Dra Cecilia Tomas. Equal collaborators of the program were Professor Leonardo D. de Castro of the Department of Philosophy, College of Social Science and Philosophy in UP Diliman, among others. The multi-disciplinary collaboration made it possible for many others to establish the Social Medicine Unit (SMU) of the College of Medicine to administer to the MS Bioethics program. It also paved the way for the establishment of a coordinated and integrated system of research ethics review in UP Manila, called the UP Manila Research Ethics Board (UPMREB).

The UPMREB created several panels, each one practically a research ethics committee, with jurisdiction over various sectors of UP Manila: faculty of the College of Medicine (who conduct most of the basic and clinical trials); resident and fellow doctors of Philippine General Hospital; and faculty and students of the various other colleges. Using the same guidelines and standard operating procedures, all the panels of the UPMREB are able to review, approve and monitor all researches in UP Manila. It was also around this time, after my few years as chair of RIDO, that intense preparations were made for the accreditation of RIDO by the Forum for Ethics Research Committees in the Asia Pacific (FERCAP). With the efforts of Dra Evangeline Santos, professor of Ophthalmology and co-graduate of mine from the Diploma in Bioethics program, assisted by other staff of the College of Medicine, FERCAP accreditation was achieved. Subsequently, UPMREB and all its panels achieved the same accreditation.

In the meantime, a law (Republic Act No. 10532), called the Philippine National Health Research System (PNHRS) was enacted in May 2013 to coordinate and integrate all stakeholders in health research in the Philippines. It is through the force of this law that the scientific community outside the University through the Department of Science and Technology (DOST) of the Philippine government, in collaboration with the Department of Education and Culture through the Commission on Higher Education (CHED) and the Department of Health, asked the NIH of UP Manila to implement a Memorandum Order which mandates that all research involving human participants shall undergo review by accredited ethics research committees (by December 2015). The DOST, through the Philippine Council for Health Research and Development (PCHRD), designated the Philippine Health Research Ethics Board (PHREB) as the policy-making body with regards to the establishment, registration, accreditation and regulation of research ethics committees in the country. Henceforth, all academic institutions, all hospitals and health care facilities, and all entities doing health and health-related research involving human participants should submit their studies to PHREB-accredited research ethics committees for review, approval and monitoring. The main objectives are to assure that research participants are not harmed (but benefitted), and that research outcomes are credible.

The PHREB, under the chairmanship of Professor Leonardo D. De Castro, created two important committees: 1). Committee on Information Dissemination, Training and Advocacy (CIDTA); and 2). Committee on Standards and Accreditation (CSA). CIDTA was initially chaired by Dra Rosario Tan-Alora, professor of internal medicine, bioethics and former dean of the college of medicine in the University of Santo Tomas. I had the privilege of being a member of her committee, which conducted trainings for nearly all hospitals and academic institutions in the country. Trainings programs were on Basic Research Ethics, on Good Research Practice, and on Standard Operating Procedures. The objective was to enable participants to create and work in research ethics committees of their respective institutions, be they hospitals or academes. Very recently, Dra Alora decided to turn over the chairmanship of CIDTA to me, although she continues to be an invaluable member/mentor. And more recently, CIDTA is preparing to embark on including a Good Clinical Practice module among its training programs.

The other committee (CSA), initially chaired by Dra Cecilia Tomas, has been in charge of setting standards for research ethics committees all over the country, registering them, and assessing them for accreditation. Three levels of accreditation have been established by CSA: Level 1 are research ethics committees capable of reviewing all types of protocols, except clinical trials; Level 2 are research ethics committees capable of reviewing even clinical trials but not those for products intended for registration with the Philippine Food and Drug Administration (FDA). Both committees had been busy the past 2 years. From a few accredited research ethics committees a couple of years ago, there are now 72 all over the country, many of them Level 3! (See http://ethics.healthresearch.ph for a complete listing)

The Philippine Council for Health Research and Development (PCHRD), recognizing the existence of research projects whose proponents may not be affiliated with institutions with accredited research ethics committees, and in fact providing funds for some such projects, reactivated the National Ethics Committee (NEC). Chaired by Dra Marita Reyes, the NEC is essentially a research ethics committee composed of multi-sectoral recruited volunteers, myself recently included representing the medical field, which reviews research proposals referred to it by the Department of Health and PCHRD. In 2011, the PHREB published the National Ethical Guidelines for Health Research, providing written, country-specific guidelines on the ethical conduct of researches on various fields. (See nec.pchrd.dost.gov.ph). Currently, a technical working group headed by Dra Marita V.T. Reyes, with me as one of the members, is in the final stages of updating the guidelines for 2017!

My personal journey in the world of research ethics continues in my newly-assigned tasks of handling classes in the MS Bioethics graduate program, specifically handling Research Ethics and Research Ethics Review classes. From the one-man, practically ambush approval of my very first international research collaboration, to the current legislated and well-established research ethics system, I have been a privileged witness, albeit by twists of fate more than intent design on my part in many instances, to the evolving developmental history of research ethics in the Philippines. This narration is by no means the complete accurate picture. It is a humble and modest attempt to share a part of my career in the academe as a professional doctor taking care of patients, teaching younger colleagues, doing research on the side, and performing administrative functions.

I am grateful to Dr Gary Allen for the opportunity.

Submitted 16 April 2017.
Revised 24 April 2017 after obtaining permission (and more accurate inputs) from the persons whose names were included in the article.

Contributor
Ricardo Manalastas, Jr., MD, MSc (Bioethics) is a professor of Obstetrics & Gynecology, Infectious Diseases and Bioethics at the College of Medicine, University of the Philippines, Manila, and Attending obstetrician gynecologist at the Philippine General Hospital.
He can be reached by email at rmmanalastasmd@me.com  | rmmanalastasmd@yahoo.com

This post may be cited as:
Manalastas R. (2017, 24 April) Research Ethics in the Philippines: a personal journey. Research Ethics Monthly. Retrieved from: https://ahrecs.com/uncategorized/research-ethics-philippines-personal-journey

A place for expedited ethics review of time-critical above-low risk research2

 

“Have you got ethics yet?” is a question asked frequently where health, social and behavioural sciences postgrads gather on campus. The amount of time human research ethics committees take to approve an application is also a common topic of conversation among university staff. Researchers often, it seems, grumble about delays in beginning their data collection while their ethics application awaits approval. As a recently retired chair of an ethics committee I confess that I rarely felt sympathy for these grumblers. Mostly, it seemed to me, they simply failed to plan their research time-line to match the clearly stated realities of the ethics application and approval process. However, I believe that ethics committees need to have in place processes which can take accommodate an important issue in need of research which has arisen unexpectedly and where data collection is time critical—such as following a disaster event where agencies need researchers to be in the field collecting data from those affected before the quality of the information is compromised with the passage of time.

Starting with the 2009 Victorian Black Saturday bushfires (173 deaths, 2029 homes destroyed) I have been involved in several post-bushfire field research interview surveys of affected householders about their pre-fire bushfire risk perceptions, plans and preparations, and their decisions and actions during the fire. The studies were conducted at the request of fire and emergency management agencies. No adverse incidents occurred. The findings have assisted agencies in reviewing and refining their community bushfire safety policies and procedures. A good case can be made that the timely information gained by the post-bushfire interview research has contributed to improved householder bushfire safety.

In the post-bushfire research where I was the chief investigator 2011 – 2014, approval of these above-low risk studies by my university’s Human Ethics Committee was speedy—within 72 hours. Each application was in the form of a modification of an originally-approved application from 2009. However, colleagues across a range of institutions have told me that it would be very difficult for them to undertake similar post-disaster research because of the time that would be required to obtain approval of such above-low risk research from their human research ethics committee. Concerned about this apparent situation, I decided to investigate how many Australian university human research ethics committees (UHRECs) had provisions for expedited review of above-low risk research.

In a collaboration with the Bushfire and Natural Hazards CRC, I sent a short survey questionnaire to all 39 Australian UHRECs in mid-2014. There were 28 responses (72%). Nine (32%) of the 28 reported having provisions for expedited review of above-low risk research; four described formal arrangements, five described ad hoc arrangements at the Chair’s discretion. Nineteen (68%) had no such provisions. Six of these 19 (32%) described possibilities if the circumstances were sufficiently compelling, the remaining 13 stated simply that they had no such provision. Six UHRECs described preferred arrangements for researchers to submit a generic application well in advance of an actual event and obtain provisional approval, and then submit a detailed application for modification when the specifics were known. A detailed report of findings is at http://www.bnhcrc.com.au/publications/biblio/bnh-1881

I believe that UHRECs which have no provisions for expedited review of above-low risk research do their institution, and the wider society, a disservice.

Jim McLennan is an adjunct professor in the School of Psychology and Public Health at La Trobe University, Melbourne. You can access Jim’s La Trobe University profile here and he can be contacted at J.McLennan@latrobe.edu.au.

This blog may be cited as:
McLennan, J. (2016, 22 February) A place for expedited ethics review of time-critical above-low risk research. Research Ethics Monthly. Retrieved from: https://ahrecs.com/uncategorized/a-place-for-expedited-ethics-review-of-time-critical-above-low-risk-research

Sprinting to the start line: concerns with expedited ethics review2

 

Allow me to start with a short story.

A recent conversation I had with an established academic evolved as follows. The academic had funding to explore how involvement with classical music impacted a child’s development. He planned to interview parents of children, aged 2-13, who played musical instruments. The interviews were exploring how music was involved in the children’s daily schedule. The questions were likely to centre around everyday activities and conversations the parents had with their family and friends, so he considered the research low risk. Expedited ethics review was gained, and the research was approved almost immediately. Upon ethics approval, the researcher then explained how he used the amendment process to include children in the research; something he had planned to do all along. The amendment involved a small submission explaining how the research was differing and what some of the new potential ethical issues might be. The interviews with the children would be about their experiences playing musical instrument. They were likely to mimic conversations the children had daily. This manipulative even blasé approach to ethics review concerned me. The researcher here took advantage of the low risk expedited review, using it as a short cut to dodge full ethics review which would have involved lengthy paperwork. When I asked him about his approach he claimed it was fairly common practice in his department. It saved time and avoided unnecessary ethical bureaucratic practices.

As a budding researcher and novice ethicist, I want to make it clear from the beginning that I am not against expedited ethics review process for low risk projects, nor do I think all projects involving children are high risk. After completing and submitting a handful of ethics applications for various projects in my postgraduate studies and research assistant work, I understand the benefits of expediting low risk projects. I do, however, have some concerns with what may be lost in the rush to expedited review, particularly if expedited review is being used as a loophole.

Typically ethics committees tend to be protective of groups deemed ‘vulnerable’, children included. So my curiosity grew when I heard the ethics committee not require the academic to resubmit a full ethics application. Many ethics committees would see red flags because of the children and require a completely new application. Ethics committees’ idiosyncrasies are discussed often enough in ethics literature, and perhaps magnified through their approaches to expedited review. Yet, little explanation around the decisions to accept or reject amendments is offered. Would other ethics committees have reacted differently to the amendment submitted?

I am apprehensive that expedited ethical review may render the primary purpose of ethics review secondary. Ethics review was originally created to protect participants from harm. Expedited ethical review has definite benefits for the researcher and ethics committee, decreasing the time review takes, and reducing the workload for committee members. But does it come at a cost to participant protection?

I have two main concerns: the level of ethical scrutiny applied during expedited review; and the temptation for expedited review to be used as a ‘shortcut’. One of the main benefits of full ethics review is that research proposals are scrutinised by multiple sets of eyes, and critiqued and examined by members with different skill sets, concerns, and expertise. I am unsure how during expedited review, one or two ethics committee members can ensure the same level of review is applied. In the past, expedited review of applications I have submitted certainly missed some key mistakes which I found after receiving ethics approval. Furthermore, I am unsure if just one member of the ethics committee can identify all the potential risks of low risk projects.

The second main concern I have with expedited review is that it may be used as a ‘shortcut’. Expedited review may be seen as a way to obtain ethics review quickly. “The identification of ‘doing ethics’ with ‘getting through ethics review’ creates a risk that ethics questions focus on data gathering, with the result that (re)use of data is either seen as ethically unproblematic or ignored” (Morrow et al 2004 p. 4). Israel (2015) argues qualitative researchers are frustrated with ethics procedures that do not understand qualitative methods. The researcher’s approach to ethics review above may be a result of this frustration. However, finding loopholes and using or abusing the expedited review process should not be the answer.

My short reflection of this expedited review process is not intended to criticise ethics committee members’ work. I simply cannot fathom the volume of work they undertake each month. Introducing systems such as expedited review may be a productive way to reduce the monthly workload ethics committees face. Rather, I have questioned how thoroughly expedited review can explore a complex project. Perhaps we should be asking not if projects reviewed through an expedited review process offer the same level of ethical scrutiny as a full review process, but rather how this shortened review process can ensure projects are still reviewed sufficiently?

References

Israel, M. (2015). Research ethics and integrity for social scientists: Beyond regulatory compliance (2nd ed.). London: Sage.

Morrow, V.; Boddy, J.; Lamb, R. The ethics of secondary data analysis: Learning from the experience of sharing qualitative data from young people and their families in an international study of childhood poverty. Institute of Education, University of London, UK (2014) 24 pp.

Amber Chambers
Otago University MA graduate
Research assistant at Griffith University
Centre for Governance and Public Policy, Nathan

This blog may be cited as:
Chambers, A (2015, 23 August) Sprinting to the start line: concerns with expedited ethics review. AHRECS Blog. Retrieved from https://ahrecs.com/human-research-ethics/sprinting-to-the-start-line-concerns-with-expedited-ethics-review

 

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